HOVON 171 AML: A single arm phase II trial to assess cobicistat boosted venetoclax in combination with azacitidine in patients with newly diagnosed acute myeloid leukaemia (AML) who are not considered candidates for intensive treatment regimens

Conditions

Acute Myeloid Leukaemia

Brief summary

Run-in phase: Pharmacokinetic equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2)., Extension phase: Overall survival (OS)

Detailed description

Run-in phase: Venetoclax and cobicistat CL, Cmax, Tmax, Cmin and AUC0-24., Extension phase: Response rate (CR, CRi, CR/CRi, CRh, CR/CRh, CRMRD-, CR/CRiMRD-, CR/CRhMRD-, and MLFS)., Event free survival (EFS)., Relapse-free survival (RFS)., Incidence and severity of adverse events according to CTCAE version 5.0., Early (30-day and 60-day) mortality (in general, non-leukemic)., Time to next cycle, defined as the time from the start of the cycle until the start of the next cycle., OS of AZA/VEN/COBI treated patients in comparison with a real-world data cohort treated during the same time period and monitored by the Dutch Cancer registry., Prognostic/predictive impact of disease-associated genetic changes at diagnosis., Relapse-associated genetic changes (determined at relapse)., Clonal evolution during treatment., Exposure-response and exposure-toxicity relation of venetoclax in patients with AML., Cost-savings on venetoclax drug costs., Adherence to venetoclax and cobicistat.

Related papers

No related papers found yet.

Interventions

DRUGVENETOCLAX

DRUGCOBICISTAT

DRUGAZACITIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Run-in phase: Pharmacokinetic equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2)., Extension phase: Overall survival (OS)	—

Secondary

Measure	Time frame
Run-in phase: Venetoclax and cobicistat CL, Cmax, Tmax, Cmin and AUC0-24., Extension phase: Response rate (CR, CRi, CR/CRi, CRh, CR/CRh, CRMRD-, CR/CRiMRD-, CR/CRhMRD-, and MLFS)., Event free survival (EFS)., Relapse-free survival (RFS)., Incidence and severity of adverse events according to CTCAE version 5.0., Early (30-day and 60-day) mortality (in general, non-leukemic)., Time to next cycle, defined as the time from the start of the cycle until the start of the next cycle., OS of AZA/VEN/COBI treated patients in comparison with a real-world data cohort treated during the same time period and monitored by the Dutch Cancer registry., Prognostic/predictive impact of disease-associated genetic changes at diagnosis., Relapse-associated genetic changes (determined at relapse)., Clonal evolution during treatment., Exposure-response and exposure-toxicity relation of venetoclax in patients with AML., Cost-savings on venetoclax drug costs., Adherence to venetoclax and cobicistat.	—

Measure

Time frame

Run-in phase: Venetoclax and cobicistat CL, Cmax, Tmax, Cmin and AUC0-24., Extension phase: Response rate (CR, CRi, CR/CRi, CRh, CR/CRh, CRMRD-, CR/CRiMRD-, CR/CRhMRD-, and MLFS)., Event free survival (EFS)., Relapse-free survival (RFS)., Incidence and severity of adverse events according to CTCAE version 5.0., Early (30-day and 60-day) mortality (in general, non-leukemic)., Time to next cycle, defined as the time from the start of the cycle until the start of the next cycle., OS of AZA/VEN/COBI treated patients in comparison with a real-world data cohort treated during the same time period and monitored by the Dutch Cancer registry., Prognostic/predictive impact of disease-associated genetic changes at diagnosis., Relapse-associated genetic changes (determined at relapse)., Clonal evolution during treatment., Exposure-response and exposure-toxicity relation of venetoclax in patients with AML., Cost-savings on venetoclax drug costs., Adherence to venetoclax and cobicistat.

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Countries

Netherlands

Outcome results

None listed